Gap Analysis Against ISO 13485:2016 Medical Device Standard
To review and conduct gap analysis for the reference standard QMS MD 13485:2016 to define the level of Compliance within the Organization.
The team from the respective function / department shall be engaged with the Consultant / Trainer to perform the Gap Analysis guided with structured Checklist to identify gap within the function / department.
1. QA Manager
2. Regulatory Compliance Manager
3. Purchasing Manager
4. Administration Manager
5. Operations Manager
6. Any others who are directly involved in this scope of work.
A structured Gap Analysis Checklist shall be used.
DAY 1
• Module 1 : Concept , Approach and Methodology for the GAP Analysis
• Module 2 : General Section
• Module 3 : Section / Clause 4: Quality Management System
• Module 4 : Section / Clause 5: Management Responsibility
• Module 5 : Section / Clause 5: Management Responsibility (continued)
• Module 6 : Section / Clause 6: Resource Management
• Module 7 : Section/ Clause 6: Resource Management (continued)
DAY 2
• Module 8 : Section/ Clause 7: Design & Development
• Module 9 : Section/ Clause 7: Design & Development (continued)
• Module 10 : Section/ Clause 8: Measurement. analysis & improvement
• Module 11 : Group Exercise: Drafting bullet point summary
You May Also Be Interested In
Explore other training programmes that may complement your learning needs.
